Intravascular imaging procedure-specific workflow guidance and associated devices, systems, and methods

ABSTRACT

Systems, devices, and methods for providing procedure-specific workflow guidance are provided. The workflow guidance may include providing selectable options on a display device to a user including a selectable option to select a target vessel and a prompt to move an intravascular imaging device within the selected target vessel. Imaging data is received from the intravascular imaging device within the selected target vessel. The workflow guidance may be used to identify an area of interest within the selected target vessel and automatically display vessel measurements corresponding with the area of interest on the display device.

CROSS-REFERENCE TO PRIOR APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/520,472, filed 24 Jul. 2019, now U.S. Pat. No. 11,666,245, whichclaims the benefit of U.S. Provisional Application No. 62/712,009, filedon 30 Jul. 2018. These applications are hereby incorporated by referenceherein.

TECHNICAL FIELD

The present disclosure relates generally to obtaining intravascular dataassociated with a body vessel of a patient, and, in particular, toproviding a workflow to a user to perform an intravascular imagingprocedure with an intravascular imaging device. The workflow may bedisplayed to a user as prompts and instructions as well asvisualizations of imaging data from the intravascular imaging device.

BACKGROUND

Various types of intravascular imaging systems are used in diagnosingand treating diseases. For example, intravascular ultrasound (IVUS)imaging is widely used in interventional cardiology as a diagnostic toolfor assessing a diseased vessel, such as an artery, within the humanbody to determine the need for treatment, to guide the intervention,and/or to assess its effectiveness. An IVUS device including one or moreultrasound transducers is passed into the vessel and guided to the areato be imaged. The transducers emit ultrasonic energy and receiveultrasound echoes reflected from the vessel. The ultrasound echoes areprocessed to create an image of the vessel of interest.

The advent of faster computational analysis has increased theeffectiveness of intravascular imaging systems. However, existingintravascular imaging systems typically require operators to have a highdegree of skill and experience to safely operate intravascular devices.For example, depending on the type of operation, the performance of anintravascular procedure may include many steps including maneuveringdevices, measurements, and analysis of results. An operator must knowand complete all of these steps to successfully perform the procedure.The large number and complexity of steps may make these proceduresdifficult to perform and may cause errors in the procedures.

SUMMARY

Systems, devices, and methods for providing instructions for an operatorof an intravascular imaging system are provided. The intravascularimaging system may include a controller configured to provide aselectable options on a display device to select a target vessel,identify an area of interest within the selected target vessel based onthe received imaging data, and automatically display, in response toidentifying the area of interest, vessel measurements corresponding withthe area of interest on the display device. Aspects of the presentdisclosure advantageously provide complete end-to-end workflow solutionsthat overcome the limitations of existing intravascular imaging systems.

Embodiments of the present disclosure provide an intravascular imagingsystem, which may include: a controller in communication with anintravascular imaging device, the controller configured to: provide, ona display device in communication with the controller, a selectableoption to select a target vessel; provide a prompt to move theintravascular imaging device within the selected target vessel; receiveimaging data from an imaging sensor during movement of the intravascularimaging device within the selected target vessel; identify an area ofinterest within the selected target vessel based on the received imagingdata; and automatically display, in response to identifying the area ofinterest, vessel measurements corresponding with the area of interest onthe display device.

In embodiments, the intravascular imaging system further includes theintravascular imaging device, including: a flexible elongate memberconfigured to be inserted into the target vessel of a patient; theimaging sensor disposed on a distal portion of the flexible elongatemember; and the display device. The controller may be further configuredto provide a selectable option on the display device to perform apre-stent procedure or a post-stent check. The controller may be furtherconfigured to automatically measure a diameter of the vessel within thearea of interest, determine a first location within the area of interestwith a minimum diameter, and display the first location and the minimumdiameter on the display device.

In some embodiments, the display of the vessel measurements isconfigured to allow a user to edit a depiction of a border of thevessel. The display of the vessel measurements may include a first viewand a second view of the area of interest different from the first view.A user's edit to the depiction of the border of the vessel may bedisplayed in the first view and the second view of the area of interest.The display of the vessel measurements may include a depiction of atarget area for a stent if a user selects the pre-stent procedureoption. The display of the vessel measurements may include a depictionof a stent if a user selects the post-stent check option. The display ofthe vessel measurements may further include a depiction of a stentmalapposition.

A method of intravascular imaging is also provided, which may include:providing, with a controller in communication with an intravascularimaging device, a selectable option on a display device to select atarget vessel within a patient; providing, with the controller, a promptto move the intravascular imaging device in the selected target vesselon the display device; receiving, with the controller, imaging data froman imaging sensor while the intravascular imaging device is moved withinthe selected target vessel; identifying, with the controller, an area ofinterest within the selected target vessel based on the received imagingdata; and displaying automatically, with the display device, vesselmeasurements corresponding with the area of interest.

The method may also include providing, with a controller, a selectableoption on a display device to perform a pre-stent procedure or apost-stent check. The method may include measuring, with the controller,a diameter of the vessel within the area of interest, identifying afirst location with a minimum diameter within the area of interest; anddisplaying the first location and minimum diameter on the displaydevice. The method may include providing, with the controller, an optionto edit a depiction of a border of the vessel on the display device.

In some embodiments, the display of the vessel measurements includes afirst view and a second view of the area of interest different from thefirst view. The method may include displaying an edit to the depictionof the border of the vessel in the first view and the second view of thearea of interest. The method may include displaying the edit to thedepiction of the border of the vessel in a third view different from thefirst view and the second view. The display of the vessel measurementsmay include a depiction of a target area for a stent if a user selectsthe pre-stent procedure option. The display of the vessel measurementsmay include a depiction of a stent if a user selects the post-stentcheck option. The display of the vessel measurements further may includea depiction of a stent malapposition.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a diagrammatic schematic view of an intravascular imagingsystem, according to aspects of the present disclosure.

FIG. 2 is an exemplary illustration of a display showing a promptaccording to aspects of the present disclosure.

FIG. 3 is an exemplary illustration of a display showing another promptaccording to aspects of the present disclosure.

FIG. 4 is an exemplary illustration of a display showing another promptand instructions according to aspects of the present disclosure.

FIG. 5 is an exemplary illustration of a display showing imaging dataand instructions according to aspects of the present disclosure.

FIG. 6 is an exemplary illustration of a display showing imaging dataaccording to aspects of the present disclosure.

FIG. 7A is an exemplary illustration of a display showing various viewsof imaging data according to aspects of the present disclosure.

FIG. 7B is an exemplary illustration of another display showing variousviews of imaging data according to aspects of the present disclosure.

FIG. 7C is an exemplary illustration of another display showing variousviews of imaging data according to aspects of the present disclosure.

FIG. 8 is an exemplary illustration of a display showing imaging dataaccording to aspects of the present disclosure.

FIG. 9 is an exemplary illustration of a display showing imaging dataaccording to aspects of the present disclosure.

FIG. 10 is a flow diagram of a method of providing a guided workflowaccording to aspects of the present disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates. In particular, it is fully contemplated that the features,components, and/or steps described with respect to one embodiment may becombined with the features, components, and/or steps described withrespect to other embodiments of the present disclosure. For the sake ofbrevity, however, the numerous iterations of these combinations will notbe described separately.

FIG. 1 is a diagrammatic schematic view of an intravascular imagingsystem 100, according to aspects of the present disclosure. Theintravascular imaging system 100 may include an intravascular device102, a patient interface module (PIM) 104, a console or processingsystem 106, and a display device or monitor 108. The intravasculardevice 102 may be sized and shaped, and/or otherwise structurallyarranged or configured to be positioned within a body lumen 120 of apatient. For example, the intravascular device 102 can be a catheter,guide wire, guide catheter, pressure wire, and/or flow wire in variousembodiments. In some circumstances, the system 100 may includeadditional elements and/or may be implemented without one or more of theelements illustrated in FIG. 1 .

The devices, systems, and methods described herein can include one ormore features described in U.S. Provisional App. No. 62/643,105(Attorney Docket No. 2017PF02102), filed on an even date herewith, U.S.Provisional App. No. 62/642,847 (Attorney Docket No. 2017PF02103), filedon an even date herewith, U.S. Provisional App. No. 62/711,927 (AttorneyDocket No. 2017PF02101), filed on an even date herewith, and U.S.Provisional App. No. 62/643,366 (Attorney Docket No. 2017PF02365), filedon an even date herewith, each of which is hereby incorporated byreference in its entirety.

The intravascular imaging system 100 (or intraluminal imaging system)can be any type of imaging system suitable for use in the lumens orvasculature of a patient. In some embodiments, the intravascular imagingsystem 100 is an intravascular ultrasound (IVUS) imaging system. Inother embodiments, the intravascular imaging system 100 may includesystems configured for forward looking intravascular ultrasound(FL-IVUS) imaging, intravascular photoacoustic (IVPA) imaging,intracardiac echocardiography (ICE), transesophageal echocardiography(TEE), and/or other suitable imaging modalities.

It is understood that the system 100 and/or device 102 can be configuredto obtain any suitable intravascular imaging data. In some embodiments,the device 102 can include an imaging component of any suitable imagingmodality, such as optical imaging, optical coherence tomography (OCT),etc. In some embodiments, the device 102 can include any suitableimaging component, including a pressure sensor, a flow sensor, atemperature sensor, an optical fiber, a reflector, a mirror, a prism, anablation element, a radio frequency (RF) electrode, a conductor, and/orcombinations thereof. Generally, the device 102 can include a imagingelement to obtain intravascular data associated with the lumen 120. Thedevice 102 may be sized and shaped (and/or configured) for insertioninto a vessel or lumen 120 of the patient.

The system 100 may be deployed in a catheterization laboratory having acontrol room. The processing system 106 may be located in the controlroom. Optionally, the processing system 106 may be located elsewhere,such as in the catheterization laboratory itself. The catheterizationlaboratory may include a sterile field while its associated control roommay or may not be sterile depending on the procedure to be performedand/or on the health care facility. The catheterization laboratory andcontrol room may be used to perform any number of medical imagingprocedures such as angiography, fluoroscopy, CT, IVUS, virtual histology(VH), forward looking IVUS (FL-IVUS), intravascular photoacoustic (IVPA)imaging, a fractional flow reserve (FFR) determination, a coronary flowreserve (CFR) determination, optical coherence tomography (OCT),computed tomography, intracardiac echocardiography (ICE),forward-looking ICE (FLICE), intravascular palpography, transesophagealultrasound, fluoroscopy, and other medical imaging modalities, orcombinations thereof. In some embodiments, device 102 may be controlledfrom a remote location such as the control room, such than an operatoris not required to be in close proximity to the patient.

The intravascular device 102, PIM 104, and monitor 108 may becommunicatively coupled directly or indirectly to the processing system106. These elements may be communicatively coupled to the medicalprocessing system 106 via a wired connection such as a standard copperlink or a fiber optic link and/or via wireless connections using IEEE802.11 Wi-Fi standards, Ultra Wide-Band (UWB) standards, wirelessFireWire, wireless USB, or another high-speed wireless networkingstandard. The processing system 106 may be communicatively coupled toone or more data networks, e.g., a TCP/IP-based local area network(LAN). In other embodiments, different protocols may be utilized such asSynchronous Optical Networking (SONET). In some cases, the processingsystem 106 may be communicatively coupled to a wide area network (WAN).The processing system 106 may utilize network connectivity to accessvarious resources. For example, the processing system 106 maycommunicate with a Digital Imaging and Communications in Medicine(DICOM) system, a Picture Archiving and Communication System (PACS),and/or a Hospital Information System via a network connection.

At a high level, the intravascular device 102 emits ultrasonic energyfrom a transducer array 124 included in scanner assembly 110 mountednear a distal end of the intravascular device 102. The ultrasonic energyis reflected by tissue structures in the medium (such as a lumen 120)surrounding the scanner assembly 110, and the ultrasound echo signalsare received by the transducer array 124. The scanner assembly 110generates electrical signal(s) representative of the ultrasound echoes.The scanner assembly 110 can include one or more single ultrasoundtransducers and/or a transducer array 124 in any suitable configuration,such as a planar array, a curved array, a circumferential array, anannular array, etc. For example, the scanner assembly 110 can be aone-dimensional array or a two-dimensional array in some instances. Insome instances, the scanner assembly 110 can be a rotational ultrasounddevice. The active area of the scanner assembly 110 can include one ormore transducer materials and/or one or more segments of ultrasoundelements (e.g., one or more rows, one or more columns, and/or one ormore orientations) that can be uniformly or independently controlled andactivated. The active area of the scanner assembly 110 can be patternedor structured in various basic or complex geometries. The scannerassembly 110 can be disposed in a side-looking orientation (e.g.,ultrasonic energy emitted perpendicular and/or orthogonal to thelongitudinal axis of the intravascular device 102) and/or aforward-looking looking orientation (e.g., ultrasonic energy emittedparallel to and/or along the longitudinal axis). In some instances, thescanner assembly 110 is structurally arranged to emit and/or receiveultrasonic energy at an oblique angle relative to the longitudinal axis,in a proximal or distal direction. In some embodiments, ultrasonicenergy emission can be electronically steered by selective triggering ofone or more transducer elements of the scanner assembly 110.

The ultrasound transducer(s) of the scanner assembly 110 can be apiezoelectric micromachined ultrasound transducer (PMUT), capacitivemicromachined ultrasonic transducer (CMUT), single crystal, leadzirconate titanate (PZT), PZT composite, other suitable transducer type,and/or combinations thereof. In an embodiment the ultrasound transducerarray 124 can include any suitable number of individual transducersbetween 1 transducer and 1000 transducers, including values such as 2transducers, 4 transducers, 36 transducers, 64 transducers, 128transducers, 500 transducers, 812 transducers, and/or other values bothlarger and smaller.

The PIM 104 transfers the received echo signals to the processing system106 where the ultrasound image (including the flow information) isreconstructed and displayed on the monitor 108. The console orprocessing system 106 can include a processor and a memory. Theprocessing system 106 may be operable to facilitate the features of theintravascular imaging system 100 described herein. For example, theprocessor can execute computer readable instructions stored on thenon-transitory tangible computer readable medium.

The PIM 104 facilitates communication of signals between the processingsystem 106 and the scanner assembly 110 included in the intravasculardevice 102. This communication may include providing commands tointegrated circuit controller chip(s) within the intravascular device102, select particular element(s) on the transducer array 124 to be usedfor transmit and receive, providing the transmit trigger signals to theintegrated circuit controller chip(s) to activate the transmittercircuitry to generate an electrical pulse to excite the selectedtransducer array element(s), and/or accepting amplified echo signalsreceived from the selected transducer array element(s) via amplifiersincluded on the integrated circuit controller chip(s). In someembodiments, the PIM 104 performs preliminary processing of the echodata prior to relaying the data to the processing system 106. Inexamples of such embodiments, the PIM 104 performs amplification,filtering, and/or aggregating of the data. In an embodiment, the PIM 104also supplies high- and low-voltage DC power to support operation of theintravascular device 102 including circuitry within the scanner assembly110.

The processing system 106 receives echo data from the scanner assembly110 by way of the PIM 104 and processes the data to reconstruct an imageof the tissue structures in the medium surrounding the scanner assembly110. Generally, the device 102 can be utilized within any suitableanatomy and/or body lumen of the patient. The processing system 106outputs image data such that an image of the vessel or lumen 120, suchas a cross-sectional IVUS image of the lumen 120, is displayed on themonitor 108. Lumen 120 may represent fluid filled or surroundedstructures, both natural and man-made. Lumen 120 may be within a body ofa patient. Lumen 120 may be a blood vessel, as an artery or a vein of apatient's vascular system, including cardiac vasculature, peripheralvasculature, neural vasculature, renal vasculature, and/or or any othersuitable lumen inside the body. For example, the device 102 may be usedto examine any number of anatomical locations and tissue types,including without limitation, organs including the liver, heart,kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervoussystem structures including the brain, dural sac, spinal cord andperipheral nerves; the urinary tract; as well as valves within theblood, chambers or other parts of the heart, and/or other systems of thebody. In addition to natural structures, the device 102 may be used toexamine man-made structures such as, but without limitation, heartvalves, stents, shunts, filters and other devices.

The processing system or controller 106 may include a processing circuithaving one or more processors in communication with memory and/or othersuitable tangible computer readable storage media. The processing systemor controller 106 may be configured to carry out one or more aspects ofthe present disclosure. In some embodiments, the processing system 106and the monitor 108 are separate components. In other embodiments, theprocessing system 106 and the monitor 108 are integrated in a singlecomponent. For example, the system 100 can include a touch screendevice, including a housing having a touch screen display and aprocessor. The system 100 can include any suitable input device, such asa touch sensitive pad or touch screen display, keyboard/mouse, joystick,button, etc., for a user to select options shown on the monitor 108. Theprocessing system 106, the monitor 108, the input device, and/orcombinations thereof can be referenced as a controller of the system100. The controller can be in communication with the device 102, the PIM104, the processing system 106, the monitor 108, the input device,and/or other components of the system 100.

In some embodiments, the intravascular device 102 includes some featuressimilar to traditional solid-state IVUS catheters, such as the EagleEye®catheter available from Volcano Corporation and those disclosed in U.S.Pat. No. 7,846,101 hereby incorporated by reference in its entirety. Forexample, the intravascular device 102 may include the scanner assembly110 near a distal end of the intravascular device 102 and a transmissionline bundle 112 extending along the longitudinal body of theintravascular device 102. The cable or transmission line bundle 112 caninclude a plurality of conductors, including one, two, three, four,five, six, seven, or more conductors.

The transmission line bundle 112 terminates in a PIM connector 114 at aproximal end of the intravascular device 102. The PIM connector 114electrically couples the transmission line bundle 112 to the PIM 104 andphysically couples the intravascular device 102 to the PIM 104. In anembodiment, the intravascular device 102 further includes a guidewireexit port 116. Accordingly, in some instances the intravascular device102 is a rapid-exchange catheter. The guidewire exit port 116 allows aguidewire 118 to be inserted towards the distal end in order to directthe intravascular device 102 through the lumen 120.

The monitor 108 may be a display device such as a computer monitor orother type of screen. The monitor 108 may be used to display selectableprompts, instructions, and visualizations of imaging data to a user. Insome embodiments, the monitor 108 may be used to provide aprocedure-specific workflow to a user to complete an intravascularimaging procedure. This workflow may include performing a pre-stent planto determine the state of a lumen and potential for a stent, as well aschecking on a stent that has been positioned in a lumen. The workflowmay presented to a user as any of the displays or visualizations shownin FIGS. 2-9 .

FIG. 2 shows an exemplary display 200 showing a prompt 202 according toaspects of the present disclosure. In some embodiments, the display 200is displayed on the monitor 108 as shown in FIG. 1 . In otherembodiments, the display 200 is displayed on a screen of another device,such as PIM 104. The display 200 may be generated by a controller of theintravascular imaging system 100. In some embodiments, the display 200is configured to display prompts and instructions as well as other datato an operator. The display 200 may be used to show a completeend-to-end workflow for an intravascular procedure. This workflow mayinclude a number of prompts and instructions that may guide an operatorthrough a procedure. This may simplify the steps of a procedure and helpto avoid operator errors.

The prompts and instructions may be displayed on the display 200 asselectable options such that an operator may interact with the display200 to choose options. The selections of the operator may change thedisplay 200 such that information corresponding with the selectedoptions is shown. In the example of FIG. 1 , a selectable prompt 202 isdisplayed on display 200. The prompt includes two selectable options:option 204 corresponds to a pre-stent plan and option 206 corresponds toa post-stent check. The operator may select one of the options 204, 206which may move the workflow forward, such that other screens aredisplayed (such as prompt 302 as shown in FIG. 3 ). The options 204, 206may include visual representations of the type of procedure. Forexample, option 204 may include a depiction of vasculature within theheart and option 206 may include a depiction of a stent. In someembodiments, the selection of an option 204, 206 may involve a change inthe visual depiction of the option 204, 206. For example, if thepre-stent plan option 204 is selected, the option 204 may appear asshaded or grey in future displays of the display 200. This may help toindicate that this option 204 has previously been selected by anoperator. Other types of feedback may be used to indicate selections ofoptions. For example, the selectable options 204, 206 may displayblinking areas, highlighted areas, altered colors, shading, alteredtransparencies, and other visual indicators.

Option 204 may provide a workflow for a pre-stent plan that may includeperforming an intravascular procedure (such as a pullback operation) andviewing results. Option 204 may be used to identify areas within a lumen120 that may benefit from the placement of a stent. Option 206 mayprovide a workflow for a post-stent check that may include performing anintravascular procedure (such as a pullback operation) and viewingresults of an area within a lumen 120 where a stent has previously beenplaced. This option 206 may be used to observe the placement andeffectiveness of the stent.

FIG. 3 shows an exemplary display 200 showing a prompt 302 according toaspects of the present disclosure. The colors, shading, textures, andother graphical properties of the display 200 may be chosen to highlightspecific features. In some embodiments, the prompt 302 may be displayedafter either of the options 204, 206 are selected. In other embodiments,the prompt 302 is displayed only after the pre-stent plan option 204 isselected. The prompt 302 may prompt the operator to select a targetvessel. In the example of FIG. 3 , selecting the target vessel includesselecting a region on a visualization 304 including arteries in theheart. The selectable regions may include the right coronary artery(RCA), left anterior descending (LAD), and left circumflex artery (LCX).The selectable regions may also include various regions of the arteries,as well as other vessels and lumens within other parts of the anatomy ofa patient. The appearance of the visualization 304 may be altered whenone of the regions is selected by the operator. For example, theselected artery may be outlined, highlighted, or colored with adifferent color. In some embodiments, the selected artery is outlined ina contrasting color (e.g., blue, red, or another color), shaded, shownwith a texture, or otherwise highlighted.

FIG. 4 shows an exemplary display 200 showing a prompt 402 according toaspects of the present disclosure. The prompt 402 may be displayed afterthe operator has made a selection on the prompt 302 shown in FIG. 3 . Inthe example of FIG. 4 , the LAD artery has been selected by an operator.The prompt 402 shows the outlined image of the LAD along withinstructions 403 to perform a pullback procedure from the most distalpoint on the LAD to the ostium. These instructions 403 may refer to apullback procedure or other movement of the device 102 within theselected vessel or lumen 120. The instructions 403 may instruct anoperator to perform any type of movement of the device 102 within aselected target vessel. For example, the instructions 403 may instructan operator to push the device 102 a given distance along the selectedtarget vessel. A visualization 404 corresponding to the instructions 403may also be displayed on the display 200. In the example of FIG. 4 , thevisualization 404 includes a line 406 with arrows showing the directionin which the pullback procedure should be performed. The visualization404 may include visual effects such as changing colors or animation. Forexample, the arrows of the visualization 404 may move in the directionspecified by the instructions 403. The instructions 403 andvisualization 404 may vary depending on options that were previouslyselected. For example, if an operator selected the RCA as the targetvessel, the visualization 404 of the RCA would be highlighted and acorresponding visualization would be displayed showing a procedureoutlined by instructions 403.

In some embodiments, the instructions 403 of the display 200 may varydepending on which option 204, 206 was selected from the prompt 202shown in FIG. 2 . For example, if the post-stent check option 206 wasselected, the instructions may read “please perform pullback from thedistal point of the stent to the proximal point of the stent.” Otherinstructions may also be included to guide the operator to perform animaging procedure and acquire imaging data relevant to the selectedtarget vessel and/or stent.

FIG. 5 shows an exemplary display 200 showing a prompt 502 according toaspects of the present disclosure. The prompt 502 may be displayed afterthe operator has made a selection on the prompt 402 shown in FIG. 4 . Inthe example of FIG. 5 , the LAD artery has been selected by an operator.The prompt 502 may be accompanied by a visualization 504. In someembodiments, the visualization 504 shows imaging data from the device102 as the device 102 is moved through the selected target vessel. Theimaging data may be used as a reference for the operator. In particular,imaging data shown in the visualization 504 may help the operator toknow where to begin a procedure. In the example of FIG. 5 , the imagingdata may show when the device 102 is positioned at a distal end of theLAD artery so that a pullback operation may be performed. The imagingdata may also show other reference data such as areas of interest alonga lumen 120, branches of the lumen 120, problem areas within the lumen120, or other features. In some embodiments, when the device 102 isplaced at the location specified by the instructions (for example, at adistal portion of an artery), the operator may select the record button508 to begin a recording of the procedure. The display may also includean option 506 to save specific frames of imaging data before or during aprocedure.

FIG. 6 shows an exemplary visualization 310 according to aspects of thepresent disclosure. The visualization 310 may be displayed on a monitor108. The visualization 310 may present imaging data acquired by thedevice 102 during an intravascular procedure. In some embodiments, theintravascular procedure is outlined in the instructions shown in FIGS.3-5 . In some embodiments, the visualization 310 includes imaging datacorresponding to a lumen 120, such as the selected target vessel. Thevisualization 310 may include a first view 604 and a second view 610 ofthe lumen 120. In some embodiments, the first and second views 604, 610may be oriented 90 degrees apart. In the example of FIG. 6 , the firstview 604 shows imaging data corresponding to a view straight down thelumen 120 (otherwise discussed as a “longitudinal view”) and the secondview 610 shows imaging data corresponding to a transverse view of thelumen 120. In other embodiments, other views may also be shown. Forexample, in FIGS. 7A-7C, three different views are shown, including athird view 704 showing a three dimensional sectional view of the lumen120. The views 604, 610 may include corresponding imaging data.

In some embodiments, the visualization 310 may include a selected frameof imaging data received by the device 102. For example, text box 611states that the visualization 310 corresponds to frame 1556 in theexample of FIG. 6 . The operator may be able to select any frame fromthe imaging data received by the device 102. This may allow the operatorto focus on specific areas of interest in the lumen 120.

In some embodiments, measurements are performed automatically on theimaging data with a controller of the intravascular imaging system 100as the imaging data is acquired by the device 102. In the example ofFIG. 6 , measurements corresponding to a vessel boundary 608 and aminimum lumen area (MLA) 606 are displayed on the first view 604. Themeasurements may also include a vessel diameter, a center of the vessel,a vessel boundary 608 thickness, and other measurements performedautomatically by the controller. These measurements may also be shown onother views. For example, a marker 614 is placed at the MLA in thesecond view 610 that corresponds with the MLA 606 in the first view 604.This may help an operator to visualize the diameter of vessel boundariesalong the lumen 120. The measurements may be displayed in numericalformat at box 612 on the visualization 310.

Specific portions and views of the visualization 300 may be viewed by anoperator by selecting the options 620, 622, and 624. In someembodiments, option 620 corresponds with the visualization 310 shown inFIG. 6 , option 622 corresponds with the visualization 320 shown in FIG.8 , and option 624 corresponds with the visualization 330 shown in FIG.9 . An operator may select option 620 to view a longitudinal view of thelumen 120, option 622 to view a view of a lesion in the lumen 120, andoption 624 to view a stent and surrounding portion of the lumen 120. Insome embodiments, the primary view or first view 604 of each option 620,622, 624 is accompanied by a transverse view 610 of the lumen 120 asshown in FIGS. 6, 8, and 9 .

FIGS. 7A-7C show an exemplary display 700 with various views showingimaging data according to aspects of the present disclosure. The display700 may be displayed on the monitor 108. FIG. 7A shows a display 700with three different views 702, 704, 706 of imaging data. In someembodiments, view 702 is a longitudinal view of a lumen 120, view 704 isa three dimensional cross section of the lumen 120, and view 706 is atransverse view of the lumen 120. The views 702 may includevisualization of boundaries 710, 712, 714, 716 of aspects of the lumen.For example, boundary 710 may represent a vessel boundary, boundary 712may represent a MLA of a portion of the lumen 120, boundary 714 mayrepresent a central area of the lumen 120 and boundary 716 may representa three dimensional vessel boundary. Furthermore, planes 718 and 719 mayrepresent planes along which view 702 is viewed. The boundaries 710,712, 714, 716 in one view may correspond with the boundaries 710, 712,714, 716 in the other views 702, 704, 706 of the display 700. Thepresentation of different views may help an operator to visualize thesize and shape of portions of the lumen 120.

FIG. 7B shows an exemplary display 700 with a function to allow theoperator to edit one or more of the visualization of the boundaries 710,712, 714, 716. In the example of FIG. 7B, the operator may use a tool720 to select a boundary to move (in this case, boundary 710). Theselected boundary may appear as a dotted line. The boundary may be movedin any direction. In the example of FIG. 7B, an arrow 722 shows thedirection that the boundary is moved (i.e., in an outward direction). Acorresponding movement of the boundary is also shown in views 702, 706,along with arrows 722 to show the direction of movement. The operatormay move the boundaries 710, 712, 714, 716 to correct errors in imagingdata or to visualize potential outcomes of procedures (such as insertinga stent in a lumen 120).

FIG. 7C shows an exemplary display 700 after the boundary 710 has beenmoved to a new location at boundary 730. As discussed above, the views702, 704, 706 show corresponding boundaries 730, 734 that an operatorcan view together to better understand the shape of a portion of a lumen120.

FIG. 8 shows an exemplary visualization 320 showing a lesion viewaccording to aspects of the present disclosure. In some embodiments,visualization 320 corresponds to the pre-stent plan option 204 as shownin FIG. 2 . In some embodiments, the visualization 320 may be used torecommend the placement and size of a stent to address a lesion. Theserecommendations may be made automatically by the system 100 based on theimaging data received by the device 102. In particular, thevisualization 320 may be used to visualize a portion of a lumen 120 witha potential “landing zone” 834 for a stent. In some embodiments, thelanding zone 834 is an area of interest within the lumen 120 thatincludes an MLA of a portion of the lumen 120, as marked by marker 614.The landing zone 834 may be shown in profile in view 610 to show thepotential placement of the stent within the landing zone 834. A distalend marker 830 and a proximal end marker 832 of the landing zone 834 maydefine the distal and proximal extent of a potential stent. The distalend marker 830 and proximal end marker 832 may be accompanied withnumerical data 820, 822 illustrating the average diameter and plaqueburden of the lumen 120 at these locations. In some embodiments, thevisualization may also a depiction of the plaque burden 852 along thelumen 120. In some embodiments, the depiction of the plaque burden 852is automatically measured based on imaging data from the device 102. Thevisualization 320 may also include a depiction of lumen area 850. Asillustrated in FIG. 8 , the marker 614 for the MLA may be placed wherethe plaque burden is the greatest and the area of the lumen is thesmallest.

In some embodiments, the visualization 320 includes a recommended stentdiameter as shown in text box 812. This diameter may be based on thediameter of the lumen 102 as measured by the system 100.

FIG. 9 shows an exemplary visualization 330 showing a stent check viewaccording to aspects of the present disclosure. In some embodiments, thevisualization 330 is shown after the operator has selected the stentcheck option 204 and has been guided through the subsequent workflowsteps. The visualization 330 may display imaging data gathered from thedevice 102 during motion within a lumen 120 (such as a pullbackprocedure) where a stent has been placed, as well as imaging data ofsurrounding areas of the lumen.

Measurements and/or metrics corresponding to the imaging data may beperformed automatically by the intravascular imaging system anddisplayed by the visualization 330. For example, the intravascularimaging system 100 may be used to perform length measurements such asminimum, maximum, average, and mean lengths of features in the imagingdata. The effective diameter of features may also be measured. Areameasurements of features such as lumens, vessels, plaque, and thrombusmay be performed by the intravascular imaging system 100. Themeasurements may include plaque burden, percent stenosis, percentdifference, diameter stenosis, percent diameter stenosis, luminal gain,and luminal gain percentage. Furthermore, features of a stent may alsobe measured by the intravascular imaging system 100, including overallstent area, minimum stent area, average stent area, stent apposition,expansion, malapposition, and a stent score. The visualization 330 caninclude numerical values of one or more of these measurements or othergraphical representations (e.g., shading, coloring, etc.), includinggraphical representations overlaid on or displayed separately/spacedfrom tomographic, longitudinal, and/or angiographic images of a vessel.

In some embodiments, the shape and size of a lumen boundary 904 may bemeasured and displayed, as well a boundary of the stent 906. As in FIGS.6 and 8 , the boundaries may be visualized in a first view 604 as wellas a second view 610. The visualization 330 may also includemeasurements of the length of the stent. For example, the visualization330 may include a distal reference marker 930 and may include adepiction 934 of the stent. The average diameter and plaque burden atthe distal reference marker may be shown in text box 916. The minimumstent area (MSA) may also be automatically measured and displayed in thetext box 912 as well as with MSA marker 914.

In some embodiments, the visualization 330 may be used to determine theeffectiveness of a stent. For example, the visualization 330 may includemeasurements and depictions of any malapposition of the stent. Themalapposition areas 908, 936 may be shown in both the first view 604 andthe second view 610 so that an operator can better visualize themalapposition. The malapposition areas 908, 936 may have a differentcolor than other imaging data (such as red) to highlight this feature.In some embodiments, the malapposition areas 908, 936 are measuredautomatically using the imaging data collected by the device 102 duringa pullback procedure of the stent. The visualization 330 may alsoinclude an expansion score 910. In the example of FIG. 9 , the expansionscore is 80%. This may signify that the stent is mostly expanded tocontact the lumen 120, but a malapposition is present. In someembodiments, the expansion score may vary from 0% (where a stent is notyet extended within the stent) to 100% (where a stent is completelyexpanded and no malappositions are present). The expansion score 910 maybe determined automatically with the controller of the system 100 bycomparing measurements of the border of the stent 906 to the borders ofthe lumen. In some embodiments, the expansion score 910 is also based onthe plaque burden and lumen area within the vessel.

FIG. 10 is a flow diagram of a method 1000 of proving a guided workflowfor an intravascular imaging procedure to a user. In some embodiments,the steps of the method 1000 may be carried out by the intravascularimaging system 100 and associated components as shown in FIG. 1 . It isunderstood that the steps of method 1000 may be performed in a differentorder than shown in FIG. 10 , additional steps can be provided before,during, and after the steps, and/or some of the steps described can bereplaced or eliminated in other embodiments.

At step 1002, the method 1000 may include providing a guided workflow toa user. The guided workflow may be provided as a series of prompts,instructions, and visualizations that are displayed on a display device,such as monitor 108 as shown in FIG. 1 . The guided workflow may help auser to easily and accurately perform each step of an intravascularimaging procedure. The guided workflow may present different optionsbased on the selections of the user and may include checks of previoussteps to ensure that all steps of the procedure have been performed.

At step 1004, the method may include providing a selectable option for apre-stent plan or a post-stent check. The selectable option may beprovided on a display such as display 200 as shown in FIG. 2 . Theselectable option for the pre-stent plan may include performing anintravascular imaging procedure to visualize a vessel or lumen beforeinserting a stent. The selectable option for the post-stent check mayinclude performing an intravascular imaging procedure to check a stentthat has been inserted in a vessel or lumen. Each selectable option mayinclude a number of subsequent steps, as discussed below.

At step 1006, the method 1000 may include providing an option to selecta target vessel. This option may be presented visually, such aspresenting various vessels on a diagram. In some embodiments, the targetvessels are arteries within the heart, such as the RCA, LAD, and LCX. Inother embodiments, the target vessels are other lumens within the body.This step 1006 may involve providing feedback to a user, such asindicating which vessel has been selected. The feedback may includehighlighting, coloring, shading or otherwise indicating the vessel thathas been selected.

At step 1008, the method 1000 may include providing a prompt to performan operation within the selected target vessel. In some embodiments,this operation includes moving an intravascular device within thevessel. For example, the operation may be a pullback operation. In otherembodiments, the operation may be an operation to push an intravasculardevice through a portion of a lumen. The prompt may be presented in textformat and may include a visualization of the operation.

At step 1010, the method 1000 may include providing a prompt to navigatean intravascular device to a starting point in the selected targetvessel and activate sensors in the intravascular device. This prompt maybe presented with text as well as images showing where the user shouldplace the intravascular device. In some embodiments, the prompt of step1010 depends on the option selected at step 1004. For example, if theuser selected the pre-stent plan option at step 1004, the prompt at step1010 may prompt the user to navigate the intravascular device from amost distal point of the target vessel to the ostium. If the userselected the post-stent check option at step 1004, the prompt at step1010 may prompt the user to navigate the intravascular device from adistal end of the stent to a proximal end of the stent.

At step 1012, the method 1000 may include receiving imaging data fromthe intravascular device. This imaging data may help a user toaccurately navigate the intravascular device according to the prompt ofstep 1010. For example, if the prompt of step 1010 directs the user tonavigate the intravascular device from a distal end of the stent to aproximal end of the stent, the imaging data may show imaging data fromthe intravascular device as it is moved to the distal end of the stent.In some embodiments, the imaging data may include IVUS data showing thelayers of tissue on the interior of the vessel. In other embodiments,the imaging data includes data from another modality such as OCT. Thus,the imaging data may help the user to accurately perform the operationoutlined in the prompt.

At step 1014, the method 1000 may include displaying the imaging data asthe intravascular device is moved during the operation. This imagingdata may help a user to accurately perform the operation.

At step 1016, the method 1000 may include identifying an area ofinterest using the imaging data. In some embodiment, the area ofinterest is identified based on imaging data such as bordermeasurements, lumen area, plaque burden within the lumen, etc. The areaof interest may include an MLA or MSA as shown in FIGS. 6, 8, and 9 . Insome embodiments, the area of interest includes a landing zone for stentplacement or a stent that has been positioned in a lumen. The area ofinterest may be colored, highlighted, shaded, or otherwise indicated asan area of interest on a display of the imaging data. In someembodiments, the distal and proximal ends of the area of interest areshown as well as measurements of the size and position of the area ofinterest.

At step 1018, the method 1000 may include displaying vessel measurementsbased on the imaging data corresponding with the area of interest. Insome embodiments, vessel measurements such as vessel boundaries, stentboundaries, MLA, MSA, lumen area, plaque burden, and other measurementsare displayed on the display. These measurements may be showngraphically (for example, by colored lines or regions) as well astextually (for example, in text boxes). The vessel measurements may alsoinclude recommendations (such as the recommended size and position ofstents) and scores (such as stent expansion scores). The vesselmeasurements may allow a user to quickly identify problem areas within alumen as well as possible solutions.

Persons skilled in the art will recognize that the apparatus, systems,and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. An apparatus, comprising: a processor configuredfor communication with an intravascular imaging device, wherein theprocessor is configured to: receive first intravascular imaging data ofa blood vessel from the intravascular imaging device; provide a firstscreen display on a display device in communication with the processor,wherein the first screen display comprises: a first longitudinal view ofthe blood vessel based on the first intravascular imaging data; a firsttransverse view of the blood vessel based on the first intravascularimaging data, wherein the first intravascular imaging data is obtainedbefore a stent is positioned within the blood vessel such that the firstlongitudinal view and the first transverse view do not depict the stent;a first view option associated with the first screen display; and asecond view option associated with a second screen display; receive auser input selecting the second view option via an input device incommunication with the processor; receive second intravascular imagingdata of the blood vessel from the intravascular imaging device; andprovide the second screen display on the display device, wherein thesecond screen display comprises: a second longitudinal view of the bloodvessel based on the second intravascular imaging data; a secondtransverse view of the blood vessel based on the second intravascularimaging data, wherein the second intravascular imaging data is obtainedafter the stent is positioned within the blood vessel such that thesecond longitudinal view and the second transverse view depict thestent; the first view option associated with the first screen display;and the second view option associated with the second screen display. 2.The apparatus of claim 1, wherein the first screen display and thesecond screen display further comprise a third view option associatedwith a third screen display.
 3. The apparatus of claim 2, wherein theprocessor is configured to: receive a user input selecting the thirdview option via the input device; and provide the third screen displayon the display device.
 4. The apparatus of claim 3, wherein the thirdscreen display comprises: a third longitudinal view of the blood vesselbased on the first intravascular imaging data; a third transverse viewof the blood vessel based on the first intravascular imaging data; thefirst view option associated with the first screen display; the secondview option associated with the second screen display; and the thirdview option associated with the third screen display.
 5. The apparatusof claim 4, wherein the third longitudinal view of the blood vesselcomprises a potential location for the stent.
 6. The apparatus of claim5, wherein the third screen display comprises: a diameter associatedwith a proximal end of the potential location of the stent; and adiameter associated with a distal end of the potential location of thestent.
 7. The apparatus of claim 4, wherein the third longitudinal viewof the blood vessel comprises a marker identifying a location of aminimum lumen measurement.
 8. The apparatus of claim 1, wherein thesecond screen display comprises an expansion percentage of the stent. 9.The apparatus of claim 1, wherein the second longitudinal view of theblood vessel comprises an indication of stent malapposition.
 10. Theapparatus of claim 1, wherein the second longitudinal view of the bloodvessel comprises a marker identifying a location of a minimum stentexpansion.
 11. The apparatus of claim 1, further comprising theintravascular imaging device.
 12. The apparatus of claim 1, furthercomprising the display device.